One-Year Results of Pulmonary Artery Denervation for Patients with Pulmonary Arterial Hypertension
Pulmonary artery denervation (PADN) study by Shao-Liang Chen, MD, shows promising results in improving hemodynamics and exercise capacity for patients with pulmonary arterial hypertension. The trial aims to determine the one-year efficacy of PADN in Group I PAH patients through a prospective, randomized, multi-center approach. The study flow chart depicts the enrollment process and treatment comparison between PADN plus PDE-5i and sham plus PDE-5i. Key inclusion criteria involve clinically stable PAH patients aged 18-70 years without prior PAH-specific medications.
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One-Year Results of Pulmonary Artery Denervation for Patients with Pulmonary Arterial Hypertension Shao-Liang Chen, MD On Behalf of PADN-CFDA Investigators
Disclosure Shao-Liang Chen, MD The inventor of the PADN, but not the owner of the PADN patent Received speaker honoraria from Microport, Pulnovo, Boston International Scientific, Medtronic, Sinofi, and BioMed A Fellow at the Collaborative Innovation Center for Cardiovascular Disease Translational Medicine, Nanjing Medical University, China Has received grants from the National Scientific Foundation of China
Background WHO Group I pulmonary arterial hypertension (PAH) is a progressive, incurable disease, leading to premature death Previous observational studies have demonstrated that pulmonary artery denervation (PADN) improves hemodynamic and exercise capacity in patients with PAH PADN-CFDA trial has showed treatment effect of PADN for PAH patients However, the 1-year effectiveness of PADN has not been reported in a multicenter, randomized, sham-controlled trial CRT 2023 LBCT Chen et al. JACC 2015; Zhang H Chen et al. JACC: Cardiovasc Interv 2022
Aims To determine the one-year efficacy of PADN in Group I PAH patients CRT 2023 LBCT
Study Flow Chart 186 patients enrolled between January 2018 and June 2021 at 11 clinical sites in China Design DESIGN: Prospective, randomized, multi-center, sham-control clinical evaluation of pulmonary artery denervation (PADN) for patients with PAH 58 patients excluded 128 patients were randomized OBJECTIVE: To evaluate the safety and efficacy of PADN treatment at one-year follow-up PADN plus PDE-5i (N=63) Sham plus PDE-5i (N=65) PRINCIPAL INVESTIGATOR Shao-Liang Chen, MD, PhD Nanjing First Hospital, Nanjing Medical University, China Early assessment at 1-month Clinical follow-up at 1-year in 100% (N=65) Clinical follow-up at 1-year in 100% (N=63) CRT 2023 LBCT PDE-5i = phosphodiesterase-5 inhibitor
Major Inclusion Criteria Clinically stable patients aged 18 to 70 years with PAH who were not being treated with any PAH-specific medications for at least 30 days PAH was confirmed by right heart catheterization as: - mPAP 25 mmHg - PVR >3 WU - PAWP <15 mmHg - Negative acute vasoreactivity test (for idiopathic, heritable, or drug- induced PAH) CRT 2023 LBCT
Major Exclusion Criteria Patients with Group II-V pulmonary hypertension Cardiac index <1.5 L/min/m2 Creatinine clearance <30 ml/min Inflammation or cancer Tricuspid valve or pulmonary valve stenosis Pulmonary veno-occlusive disease CRT 2023 LBCT
Endpoints Outcome Time point Powered Blinded Primary endpoint -- Difference in the change in the 6MWD (m) Secondary endpoints -- PVR via RHC (Wood units) -- NT-proBNP (pg/ml) -- Clinical worsening (%) -- Satisfactory clinical response (%) -- Cardiac function via cardiac echo 12 months Superiority Yes 12 months 12 months 12 months 12 months 12 months -- -- -- -- -- Yes Site report Yes Yes Yes PVR = pulmonary vascular reistance RHC = right heart catheterization CRT 2023 LBCT
Baseline Data PADN n = 63 Sham n = 65 Age, years 41.2 11.9 39.5 11.5 Female, n (%) 57 (90.5) 49 (75.4) Idiopathic PAH, n (%) 36 (57.1) 34 (52.3) CTD-related PAH, n (%) 14 (22.2) 17 (26.2) Associated with CHD, n (%) 9 (14.3) 13 (20.0) WHO functional class III/IV, n (%) 35 (55.6) 29 (34.6) 6-minute walk distance, m 387.5 91.7 414.3 91.5 NT-proBNP, pg/ml 2679 3358 2015 2928 PVR, Woods Unit 11.7 5.6 10.3 4.5 CRT 2023 LBCT PAH=pulmonary arterial hypertension; CTD=connective tissue disease; CHD=congenital heart disease; PVR=pulmonary vascular resistance
Change in the 6-Minute Walk Distance One-year result CRT 2023 LBCT
Conclusions Treatment with PADN plus a PDE-5i was associated with a further increase in 6-minute walk distance after 6-month until to one-year follow-up compared with PDE-5i treatment alone (81.2 m vs 33.8 m). In addition, treatment with PADN reduced PVR and PAP, improved right ventricular function, reduced tricuspid regurgitation and NT-proBNP levels, and improved clinical outcomes during one-year follow-up. PADN-CFDA Trial
